A Study of Brexpiprazole in Patients With Major Depressive Disorder

NCT ID: NCT03697603

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 740 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2022-07-04

Brief Summary

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Brexpiprazole 1mg

Tablets, Oral, 1mg once daily, 14 weeks Other Name: REXULTI

Group Type: EXPERIMENTAL

Brexpiprazole

Intervention Type: DRUG

Tablets, Oral, once daily, 14 weeks

Brexpiprazole 2mg

Tablets, Oral, 2 mg once daily, 14 weeks Other Name: REXULTI

Group Type: EXPERIMENTAL

Brexpiprazole

Intervention Type: DRUG

Tablets, Oral, once daily, 14 weeks

Placebo

Tablets, Oral, once daily, 14 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Tablets, Oral, once daily, 14 weeks

Interventions

Brexpiprazole

Tablets, Oral, once daily, 14 weeks

Intervention Type: DRUG

Placebo

Tablets, Oral, once daily, 14 weeks

Intervention Type: DRUG

Other Intervention Names

REXULTI

Eligibility Criteria

Inclusion Criteria

• Outpatients, or inpatients at the time of informed consent whose treatment status can be successfully shifted to outpatient status before enrollment in the antidepressant treatment period
• Male and female patients ≥ 20 to < 65 years of age (at the time of informed consent)
• Patients who have a level of comprehension sufficient to allow them to give written informed consent to all of the observation/examination/evaluation items specified in the protocol, and who can understand the contents of the trial
• Patients with a DSM-5 classification-based diagnosis of "major depressive disorder, single episode" or "major depressive disorder, recurrent episode," and whose current episode has persisted for at least 8 weeks

Exclusion Criteria

• Women who are pregnant or breastfeeding or who have positive pregnancy test (urine) results at screening
• Sexually active male subjects or sexually active female subjects of childbearing potential, who will not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after the final

IMP administration. For birth control, 2 of the following methods must be used:

vasectomy, tubal ligation, vaginal diaphragm, intra-uterine contraceptive device (IUD), oral contraceptives, or condom with spermicide.

• Patients with a treatment history showing that all antidepressants (including those not used for the current major depressive episode) cannot be tolerated
• Patients with a history of electroconvulsive therapy
• Patients with a diagnosis of any of the following diseases according to DSM-5

1. Neurocognitive disorders

2. Schizophrenia spectrum and other psychotic disorders

3. Bipolar and related disorders

4. Feeding and eating disorders

5. Obsessive-compulsive disorder

6. Panic disorder

7. Posttraumatic stress disorder

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanko-kokorono clinic

Fukushima, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

331-102-00058

Identifier Type: -

Identifier Source: org_study_id